Nieuwe normen en richtlijnen

bekijk de tabel Medical Devices Regulation

Electromagnetic Compatibility (EMC)

Medical Devices Regulation

Legenda:

In the column 'Status' the following codes are used:

A: Amendment
B: Basic standard
C: Correction
G: Generic standard
H: Harmonised standard
P: Product standard
D: Directive
R: Regulation
TR: Technical Reference
M: Manufacturer specific requirements

The validity of the standards/directives etc. is color coded:

Green: Valid
Orange: Will be changed or replaced soon
Red: No longer valid
Blue: Transition period
Yellow: Can be used as technical reference document

Identification	Description	Status	Version	Date of issue	Remarks
European standards	Updated list of harmonised standards for Medical devices	TR	NA-	2017-11-17	--
Decision 2021/1182	Commission Implementing Decision (EU) 2021/1182 of 16 July 2021 on the harmonised standards for medical devices drafted in support of Regulation (EU) 2017/745 of the European Parliament and of the Council		NA-	2021-07-16	--
Decision 2022/6	COMMISSION IMPLEMENTING DECISION (EU) 2022/6 of 4 January 2022 amending Implementing Decision (EU) 2021/1182 as regards harmonised standards for biological evaluation of medical devices, sterilisation of health care products, aseptic processing of health care products, quality management systems, symbols to be used with information to be supplied by the manufacturer, processing of health care products and home light therapy equipment.	A	NA-	2022-01-04	--
Decision 2022/757	COMMISSION IMPLEMENTING DECISION (EU) 2022/757 of 11 May 2022 amending Implementing Decision (EU) 2021/1182 as regards harmonised standards for quality management systems, sterilisation and application of risk management to medical devices	A	NA-	2022-05-11	--
Decision 2023/1410	COMMISSION IMPLEMENTING DECISION (EU) 2023/1410 of 4 July 2023 amending Implementing Decision (EU) 2021/1182 as regards harmonised standards for sterilization of health care products and biological evaluation of medical devices	A	NA-	2023-07-04	--

Let op! Richtlijnen worden vertaald in nationale (Nederlandse) regelgeving en mogen vrij gekopieerd worden. Normen zijn echter beschermd door copyright en moeten worden gekocht. U kunt normen aanschaffen bij bijvoorbeeld NEN.

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Belangrijke mededeling:

Deze pagina’s bevatten de door Kiwa Dare meest gebruikte normen en richtlijnen. Normen die niet in dit overzicht opgenomen zijn, kunnen op aanvraag uitgevoerd worden. Een compleet overzicht van geharmoniseerde normen is opgenomen in het overzicht (indien van toepassing).

Normen CE-markering

Nieuws op het gebied van CE-markering richtlijnen en normen

Electromagnetic Compatibility (EMC)

Medical Devices Regulation

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